Novel Methods to Reduce Children's Secondhand Smoke Exposure I
概览
- 阶段
- 不适用
- 干预措施
- Dissolvable Tobacco Lozenge
- 疾病 / 适应症
- Secondhand Smoke
- 发起方
- University of Oklahoma
- 入组人数
- 89
- 试验地点
- 2
- 主要终点
- Change in child salivary cotinine
- 状态
- 已完成
- 最后更新
- 26天前
概览
简要总结
The overall aim of the current study is to determine if the use of nicotine containing products by caregivers who smoke and who are not interested in quitting, is effective in reducing children's secondhand smoke exposure.
研究者
入排标准
入选标准
- •In order to be included in the study, participants must:
- •be the primary caregiver(defined as a person who spends the most time with the child and spends a minimum of 4 hours per day in the presence of the child) of a child between the ages of 3-11 (if caregiver has more \> 1 child between 3-11 years, we will include the youngest)
- •smoke at least 10 cigarettes per day for the past year
- •indicate that they smoke around their child or in the car or home at least one time per week\]
- •have no intention of quitting smoking in the next 12-weeks
- •aged 18-65 years
- •be fluent in English
- •have no recent history of cardiovascular distress that may contraindicate medicinal nicotine lozenge use (heart attack in the past year, arrhythmia, uncontrolled hypertension)
- •not currently pregnant, planning to become pregnant, or breastfeeding
- •do not use non-cigarette tobacco (cigars, chewing tobacco)
排除标准
- •Does not meet all of the requirements of inclusion criteria
研究组 & 干预措施
Dissolvable Tobacco Lozenge
Participants received the dissolvable tobacco lozenge for use instead of cigarettes when in the presence of their child(ren) for up to 8 weeks.
干预措施: Dissolvable Tobacco Lozenge
Electronic Cigarette
Participants received the electronic cigarette for use instead of cigarettes when in the presence of their child(ren) for up to 8 weeks.
干预措施: Electronic Cigarette
Dissolvable Nicotine Lozenge (Nicorette)
Participants received the dissolvable nicotine lozenge (Nicorette) for use instead of cigarettes when in the presence of their child(ren) for up to 8 weeks.
干预措施: Nicotine polacrilex
结局指标
主要结局
Change in child salivary cotinine
时间窗: 2, 4, 8, and 12 weeks
Child salivary cotinine will be measured to assess the level of secondhand smoke exposure. We will measure the change throughout the study.
次要结局
- Change in Parent and Child Lung Function(2, 4, 8, and 12 weeks)